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Pharmacist association calls on GOB to rethink new regime for pharmaceutical industry

Posted: Tuesday, November 14, 2017. 1:33 p.m. CST.

By BBN Staff: The Government of Belize (GOB) is implementing a new regime for the pharmaceutical industry this month as the Statutory Instrument of the Food and Drugs Regulations 2017 takes effect; and the Belize Community Pharmacist Association (BCPA) is calling on the Ministry of Health to consider the impact the changes will have on the quality and reliability of medications sold to the public.

According to the BCPA, contrary to the statement made by Minister of Health, Pablo Marin, in the House of Representatives at its sitting on October 20, 2017 that “pharmacists have nothing to do with the importation of drugs,” the BCPA emphasizes that pharmacists do have a vital role to play in the industry.

The association says that pharmacists generally serve as the reference point for wholesalers, advising them which medications are being requested by doctors and the reasons behind the request.

There are also some pharmacists who directly import medications. Therefore, pharmacists play a vital role in ensuring the quality and efficacy of the medication that enters our market, the BCPA said.

With the new requirements set out in the Food and Drug Regulations for 2017, pharmacists will no longer be able to satisfy the needs of the community with drugs of quality standard that the public has become accustomed to getting from private pharmacies. We are gravely concerned that in recent times, pedigree medications which have traditionally been imported from places such as the US, UK, Germany and other first world countries are now being replaced with alternative pharmaceuticals from manufacturers in places such as Central America which may cost more and not work as well, the BCPA added.

The Association believes that these changes are being made without proper consultation.

“Minister Marin claimed in his recent statement in Parliament that his ministry has had extensive consultations over the last three years with those who have a stake in the sector, including pharmacists and distributors. However, to the best of our knowledge, the statutory instrument was only briefly mentioned at a meeting with distributors held a year ago in November 2016, when three flyers were circulated to importers defining the Good Manufacturing Practices (GMP), Certificates of Pharmaceutical Product (CPP) and Certificate of Analysis (COA). This information session cannot be considered as consultation by any stretch of the imagination,” the release explains.

The BCPA says that no effort was made to engage the association in the crafting of the regulations.

The BCPA executive has met with health authorities only once and on the occasion of that July 25, 2017, meeting with the Director of Health Services to introduce the BCPA and its executives, we subsequently learned that the new statutory instrument had been signed that very day, the association said.

Marin also said in his recent statement to Parliament that illegal medications and fake medications are coming into our country, and he furthermore claimed that there are a lot of pharmacies that are selling controlled drugs without a registered pharmacist in their employment, resulting in deaths. The Belize Community Pharmacist Association questions the veracity of this statement and asks if this overstatement is being used in place of facts.

The BCPA noted that the pharmaceutical industry in Belize is highly regulated and pharmacists are subject to the highest level of scrutiny and inspection. There are regulatory bodies in the Ministry of Health that are charged with enforcement on behalf of the competent authorities based on existing laws that regulate pharmaceuticals. The Director of Health Services is the competent authority for the importation of pharmaceuticals and controlled drugs into Belize.

Apart from the Food and Drug regulations, other legislation pertinent to the sector are the Chemist and Druggist Act, which sets out guidelines for professionals in the sector; the Misuse of Drugs Act, which governs the importation of controlled pharmaceuticals; and the Antibiotics Act, under which the importation of antibiotics is regulated.

Belize is also guided by international conventions on Narcotics and Psychotropic Substances.

As of November 1, all pharmaceutical facilities must have a Ministry of Health Certificate of Registration License in order to provide services to the public.

 According to the Ministry of Health, there are 50 pharmaceutical importers/wholesalers and 120 retail pharmacies countrywide, but prior to the change, only 23 wholesalers and 37 retail pharmacies had a valid Ministry of Health license.

The BCPA is also seriously concerned that some supermarkets, corner stores and restaurants are selling over-the-counter and prescription drugs that are sometimes repackaged and stored under poor conditions.

The association further calls on the Ministry of Health to address the contraventions of the laws.

The BCPA supports the commitment of the Ministry of Health to work towards enhancing the pharmaceutical services being provided in the country to protect and safeguard the health of all Belizeans.

The association is requesting a meeting with the Minister of Health to engage him on the critical issues affecting the sector in a manner that will achieve our mutual aims, the release said.

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